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The Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts are intended for single use cemented total knee arthroplasty procedures with the following indications:

• 1. Loss of knee joint configuration and joint function.
• 2. Osteoarthritis of the knee joint.
• 3. Rheumatoid arthritis of the knee joint.
• 4. Post-traumatic arthritis of the knee joint.
• 5. Valgus, varus, or flexion deformities of the knee joint.
• 6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System TriMax™ CR femoral component is a highly polished Co-Cr-Mo cruciate retaining femoral component that is designed to accommodate increased range of motion up to 150° of flexion. E-Vitalize® CR and UC tibial inserts are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE (same material as K131337). All components are single use only and the TriMax™ CR femoral component is intended for cemented use only.

The E-Vitalize® CR and UC tibial inserts may be used with TriMax™ CR or BKS CR femoral components. E-Vitalize® CR and UC tibial inserts may also be used with all Ortho Development's tibial tray component offerings. The TriMax™ CR femoral component may be used with all Ortho Development patella component offerings.

The provided text is a 510(k) summary for the Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts. It does not describe a study involving detailed acceptance criteria, sample sizes, expert adjudication, or AI performance metrics as requested in the prompt. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, focusing on design, materials, and mechanical performance rather than clinical study data from human subjects or AI-driven analysis.

Therefore, I cannot extract the requested information from the provided text. The document details the product description, intended use, technological characteristics, and predicate devices, along with a list of non-clinical evaluations performed. However, it does not provide:

1. A table of acceptance criteria and reported device performance: The document mentions "non-clinical evaluations were performed and demonstrated substantial equivalence," but does not list specific acceptance criteria or corresponding performance values for these evaluations.
2. Sample size used for the test set and data provenance: The document refers to "non-clinical evaluations" but does not specify test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts and their qualifications for ground truth: This information is irrelevant for a non-clinical evaluation submission.
4. Adjudication method for the test set: Irrelevant for non-clinical evaluations.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human reader improvement with AI: This is not an AI device, so an MRMC study related to AI assistance is not applicable.
6. Standalone (algorithm only) performance: This is not an AI device, so standalone algorithm performance is not applicable.
7. Type of ground truth used: Irrelevant for non-clinical mechanical testing.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section merely states: "The following non-clinical evaluations were performed and demonstrated substantial equivalence to the predicate devices: Range of Motion, Femorotibial Constraint, Femorotibial Contact Area, Patellofemoral Constraint, Patellofemoral Contact Area, Femoral Component Fatigue Strength, Insert Assembly/Disassembly, and Knee Wear." This indicates that mechanical and material testing was conducted to show the new device performs similarly to existing, legally marketed devices, which is the basis for 510(k) clearance.

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